A Study to Evaluate Safety/Tolerability of Immunotherapy Combinations in Participants With Triple-Negative Breast Cancer or Gynecologic Malignancies
Public ClinicalTrials.gov record NCT03719326. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Breast or Gynecologic Malignancies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 1/1b, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of etrumadenant (AB928) in combination with pegylated liposomal doxorubicin (PLD) with or without IPI-549 in participants with advanced metastatic triple-negative breast cancer (TNBC) or ovarian cancer, and etrumadenant in combination with nanoparticle albumin-bound-paclitaxel (NP) in participants with advanced metastatic TNBC.
Study identification
- NCT ID
- NCT03719326
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 35 participants
Conditions and interventions
Interventions
- Etrumadenant Drug
- IPI-549 Drug
- Pegylated liposomal doxorubicin (PLD) Drug
- nanoparticle albumin-bound paclitaxel (NP) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 14, 2018
- Primary completion
- Jun 30, 2021
- Completion
- Jul 1, 2021
- Last update posted
- May 23, 2024
2018 – 2021
United States locations
- U.S. sites
- 20
- U.S. states
- 12
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scottsdale Healthcare Hospitals dba Honor Health Research Institute | Scottsdale | Arizona | 85258 | — |
| Arizona Clinical Research Center | Tucson | Arizona | 85715 | — |
| University of California, Los Angeles | Los Angeles | California | 90095 | — |
| Rocky Mountain Cancer Centers (Aurora) | Aurora | Colorado | 80012 | — |
| Miami Cancer Institute at Baptist Health | Miami | Florida | 33176 | — |
| Maryland Oncology Hematology, PA | Rockville | Maryland | 20850 | — |
| HealthPartners Institute Cancer Care Center | Saint Paul | Minnesota | 55101 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | — |
| Carolina BioOncology Institute | Huntersville | North Carolina | 28078 | — |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | 97401 | — |
| Texas Oncology, P.A. - Austin (Midtown) | Austin | Texas | 78705 | — |
| Texas Oncology, P.A. - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Texas Oncology, P.A. - Fort Worth Cancer Center | Fort Worth | Texas | 76104 | — |
| Texas Oncology, P.A. - San Antonio Northeast | San Antonio | Texas | 78217 | — |
| Texas Oncology, P.A. - San Antonio Medical Center | San Antonio | Texas | 78240 | — |
| Texas Oncology, P.A. - Tyler | Tyler | Texas | 75702 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| Medical Oncology Associates dba Summit Cancer Centers | Spokane | Washington | 99216 | — |
| MultiCare Regional Cancer Center | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03719326, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 23, 2024 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03719326 live on ClinicalTrials.gov.